Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Day 1

Overview of regulatory guidance

• Control of ordinary and mutagenic organic impurities (ICH Q and M guidance’s)
• Distinction between synthetic impurities and degradation products
• Safety of impurities (ICH S guidance’s)
• Residual solvents and elemental impurities
• Extractables and leachables

Case study: nitrosamines in valsartan tablets manufactured by Zhejiang Huahai Pharmaceuticals

Identifying new drug degradation products

• Early information: retention time and UV spectrum
• LC-MS: ionisation and mass analyser types vs. information quality
• NMR
• IR
• Concentration by fraction collection or selective extraction
• Confirmation of identity/toxicity by synthesis
• Drug product stress studies to confirm mechanism of formation

Chirality and toxicity

Day 2

Qualifying/justifying limits for new degradation products

Genotoxic impurities – structural alerts and tests for genotoxicity

Toxicology testing in animals – rationale and types of test

Routes of administration and toxicity

Risk assessments

• New degradation products
• Nitrosamines
• Elemental impurities
• Residual solvents

Worked example: elemental impurities risk assessment

Dr. Mark Powell

is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff in technical writing.

In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.

Mark not only brings a huge amount of knowledge and experience to his workshops but excellent at delivering interactive and engaging courses with multiple examples throughout.